Policyholder Services

Academy Warns of Voluntary Recall of Certain Sterile Products Distributed by Beacon Hill Medical Pharmacy/Rxtra Solutions

The Academy is alerting members of a voluntary nationwide recall of all lots of certain sterile products used by ophthalmologists. The products, compounded by Beacon Hill Pharmacy/Rxtra Solutions in Southfield, Mich., were prescribed by physicians to individual patients according to their prescription order. The recall includes:

Dexamethasone sodium phosphate 10 mg/ml injectable
Methylprednisolone acetate 40 mg/ml and 80 mg/ml injectable
Procaine p/f 20 mg/ml injectable
Triamcinolone acetonide 80 mg/ml injectable suspension

Beacon Hill said in a press release that it is recalling the affected products after the U.S. Food and Drug Administration questioned their sterility assurance. The affected products include lot numbers beginning with code 01012013@1 to 07262013@99.

Customers with affected items should stop using the products immediately and contact Beacon Hill at 800.518.9831 for further instructions on product return. The pharmacy is notifying its customers by phone and formal letter.

Any adverse events or side effects related to Beacon Hill products should be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Online at www.fda.gov/MedWatch/report.htm; or
Download or call 800.332.1088 to request a reporting form. Return the form to the address provided therein or fax to 800.332.0178.

For more information, contact the Academy’s Governmental Affairs Division at 202.737.6662.